製品技術マネージャー/ Product Technical Manager

A global pharmaceutical company is searching for a Product Technical Manager. The chosen applicant will own product process knowledge and ensure robust, validated manufacturing through technical oversight and cross-functional collaboration.

Responsibilities:

• Own end-to-end process knowledge for assigned products from late-stage development through the commercial lifecycle
• Maintain oversight of process capability through CPV, data trending, and statistical analysis to ensure robust and validated processes
• Ensure seamless flow of product and process knowledge across functions and internal sites
• Provide second-line technical and scientific process support to internal manufacturing sites
• Collaborate with cross-functional teams to evaluate changes, deviations, complaints, and CAPAs
• Serve as a single point of contact for all product-specific process topics within GPS and internal sites
• Create, maintain, and update product-specific Quality Risk Analyses (QRAs)
• Track and analyse CPV parameters, CPPs, IPCs, quality attributes, and raw material characteristics
• Conduct regular product-specific data trending and statistical analysis to identify capability issues and trends
• Issue and approve quarterly and annual data trending reports and align conclusions with site leadership
• Act as MSAT Technical Transfer Lead for assigned projects, serving as SPOC for sending and/or receiving sites
• Lead technology transfer activities including documentation, execution, and scale-up at assigned sites
• Initiate and support cross-functional investigations and continuous improvement projects based on data analysis
• Lead process qualification and validation activities, including preparation, review, and approval of protocols and reports
• Participate in and, when required, lead change controls for assigned products and processes
• Review APR/PQR data and provide appropriate technical assessment and discussion

Requirements:

• Bachelor’s degree or above in pharmacy, pharmaceutical technology, chemistry, engineering, or related fields
• 5-8 years of experience in pharmaceutical and chemical manufacturing process development and lifecycle management as Production Manager, Process Development Expert, or comparable
• Prior Project Management and team leadership experience
• Comprehensive knowledge in pharmaceutical or chemical technologies, such as API, Drug Product formulation, fill and finish (solutions, emulsions, and suspensions)
• Sound experience in data handling and applied statistics
• Fundamental understanding of international regulatory cGxP requirements across multiple health authorities (US, EU, JP); China is a plus
• Fundamental understanding of standard pharmaceutical analytical testing and methods development
• Fluent level English
  

Preferred Requirements:

• Master’s degree or equivalent
• Possess a valid 5S or 6S Lean Six Sigma Certification
• Proficient in Japanese and other languages

About the Company:

A global leader in the ophthalmology industry, this company specialises in developing innovative treatments to improve eye health worldwide. With a strong commitment to research and patient-centred solutions, it offers a dynamic environment where professionals can make a meaningful impact in healthcare.

Keywords:

製薬, 化学, 工学, 製品開発, 外資系

Job Ref: FFU0FJ